Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting

Patricia Diana Sørensen, Erik Hugger Jakobsen, Sven Tyge Langkjer, Susanne Bokmand, Birthe Østergaard, Dorte Aalund Olsen, Jonna Skov Madsen, Ivan Brandslund

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

Udgivelsesdato: 2009-null
OriginalsprogEngelsk
TidsskriftClinical Chemistry and Laboratory Medicine
Vol/bind47
Udgave nummer9
Sider (fra-til)1117-23
Antal sider6
ISSN1434-6621
DOI
StatusUdgivet - 1. jan. 2009

Fingeraftryk

Oncology
Monitoring
Serum
Tissue
human ERBB2 protein
Fluorescence
Medical imaging

Citer dette

Sørensen, Patricia Diana ; Jakobsen, Erik Hugger ; Langkjer, Sven Tyge ; Bokmand, Susanne ; Østergaard, Birthe ; Olsen, Dorte Aalund ; Madsen, Jonna Skov ; Brandslund, Ivan. / Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting. I: Clinical Chemistry and Laboratory Medicine. 2009 ; Bind 47, Nr. 9. s. 1117-23.
@article{89541d70da7a11deb0fe000ea68e967b,
title = "Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting",
abstract = "BACKGROUND: The purpose of this study was to determine the positive predictive value (PPV) of positive serum human epidermal growth factor receptor-2 (HER-2) for monitoring women with breast cancer following diagnosis and treatment in a routine clinical setting. METHODS: Serum HER-2 was measured in 1348 patients with breast cancer: 837 during routine oncology clinic visits and 511 following new diagnosis. All patients with positive serum HER-2, 1/5 of negative patients from the oncology clinic, and all the newly diagnosed were followed; a total of 862 patients. Serum HER-2 was measured using the Bayer ADVIA Centaur assay. Tissue HER-2 was determined using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). IHC +3 or IHC +2 and FISH>2.0 were positive. Patients were considered to have positive serum HER-2 when at least two values were >15 ng/mL. Recurrence, progression and regression were diagnosed according to usual clinical practice. Serum HER-2 concentrations did not contribute to diagnostic decision-making or selection of treatment. RESULTS: From January 2004 to January 2009, 149 patients were found to have positive serum HER-2. Of these, 35 were tissue HER-2 positive at surgery, 69 tissue-negative and 45 were not determined. Fifty-five of 149 that were serum HER-2 positive (37{\%}, 95{\%} CI: 29-45) had metastases. Among the 35 tissue-positive patients, 25 had recurrence in the form of metastases and there was good correlation between recurrence/progression and increase in serum HER-2 (p<0.0003). There was also a high correlation between effect of treatment and decline in serum HER-2 (p<0.0003). Of the 69 tissue-negative patients, 29 had recurrence in the form of metastases, and there was good correlation with serum HER-2 levels (p<0.000004). In this routine application of serum HER-2, the PPV for metastases recurrence detection in both tissue-positive and tissue-negative was 54 of 104 (52{\%}, 95{\%} CI: 42{\%}-62{\%}), in tissue-positive 25 of 35 (71{\%}, 95{\%} CI: 54{\%}-85{\%}), in tissue-negative 29 of 69 (42{\%}, 95{\%} CI: 30{\%}-54{\%}). The lead time of increases in serum HER-2 before recurrence could be determined in ten tissue-positive patients was 3-24 months (mean 11.3 months), when compared to standard clinical imaging methods. CONCLUSIONS: Serum HER-2 is a useful marker for the detection of recurrence of breast cancer and for monitoring the effect of treatment, especially in tissue HER-2 positive patients.",
keywords = "Adult, Aged, Breast Neoplasms, Disease Progression, Female, Humans, Middle Aged, Neoplasm Metastasis, Neoplasm Recurrence, Local, Receptor, erbB-2",
author = "S{\o}rensen, {Patricia Diana} and Jakobsen, {Erik Hugger} and Langkjer, {Sven Tyge} and Susanne Bokmand and Birthe {\O}stergaard and Olsen, {Dorte Aalund} and Madsen, {Jonna Skov} and Ivan Brandslund",
year = "2009",
month = "1",
day = "1",
doi = "10.1515/CCLM.2009.241",
language = "English",
volume = "47",
pages = "1117--23",
journal = "Clinical Chemistry and Laboratory Medicine",
issn = "1434-6621",
publisher = "Walterde Gruyter GmbH",
number = "9",

}

Sørensen, PD, Jakobsen, EH, Langkjer, ST, Bokmand, S, Østergaard, B, Olsen, DA, Madsen, JS & Brandslund, I 2009, 'Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting', Clinical Chemistry and Laboratory Medicine, bind 47, nr. 9, s. 1117-23. https://doi.org/10.1515/CCLM.2009.241

Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting. / Sørensen, Patricia Diana; Jakobsen, Erik Hugger; Langkjer, Sven Tyge; Bokmand, Susanne; Østergaard, Birthe; Olsen, Dorte Aalund; Madsen, Jonna Skov; Brandslund, Ivan.

I: Clinical Chemistry and Laboratory Medicine, Bind 47, Nr. 9, 01.01.2009, s. 1117-23.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Serum HER-2 concentrations for monitoring women with breast cancer in a routine oncology setting

AU - Sørensen, Patricia Diana

AU - Jakobsen, Erik Hugger

AU - Langkjer, Sven Tyge

AU - Bokmand, Susanne

AU - Østergaard, Birthe

AU - Olsen, Dorte Aalund

AU - Madsen, Jonna Skov

AU - Brandslund, Ivan

PY - 2009/1/1

Y1 - 2009/1/1

N2 - BACKGROUND: The purpose of this study was to determine the positive predictive value (PPV) of positive serum human epidermal growth factor receptor-2 (HER-2) for monitoring women with breast cancer following diagnosis and treatment in a routine clinical setting. METHODS: Serum HER-2 was measured in 1348 patients with breast cancer: 837 during routine oncology clinic visits and 511 following new diagnosis. All patients with positive serum HER-2, 1/5 of negative patients from the oncology clinic, and all the newly diagnosed were followed; a total of 862 patients. Serum HER-2 was measured using the Bayer ADVIA Centaur assay. Tissue HER-2 was determined using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). IHC +3 or IHC +2 and FISH>2.0 were positive. Patients were considered to have positive serum HER-2 when at least two values were >15 ng/mL. Recurrence, progression and regression were diagnosed according to usual clinical practice. Serum HER-2 concentrations did not contribute to diagnostic decision-making or selection of treatment. RESULTS: From January 2004 to January 2009, 149 patients were found to have positive serum HER-2. Of these, 35 were tissue HER-2 positive at surgery, 69 tissue-negative and 45 were not determined. Fifty-five of 149 that were serum HER-2 positive (37%, 95% CI: 29-45) had metastases. Among the 35 tissue-positive patients, 25 had recurrence in the form of metastases and there was good correlation between recurrence/progression and increase in serum HER-2 (p<0.0003). There was also a high correlation between effect of treatment and decline in serum HER-2 (p<0.0003). Of the 69 tissue-negative patients, 29 had recurrence in the form of metastases, and there was good correlation with serum HER-2 levels (p<0.000004). In this routine application of serum HER-2, the PPV for metastases recurrence detection in both tissue-positive and tissue-negative was 54 of 104 (52%, 95% CI: 42%-62%), in tissue-positive 25 of 35 (71%, 95% CI: 54%-85%), in tissue-negative 29 of 69 (42%, 95% CI: 30%-54%). The lead time of increases in serum HER-2 before recurrence could be determined in ten tissue-positive patients was 3-24 months (mean 11.3 months), when compared to standard clinical imaging methods. CONCLUSIONS: Serum HER-2 is a useful marker for the detection of recurrence of breast cancer and for monitoring the effect of treatment, especially in tissue HER-2 positive patients.

AB - BACKGROUND: The purpose of this study was to determine the positive predictive value (PPV) of positive serum human epidermal growth factor receptor-2 (HER-2) for monitoring women with breast cancer following diagnosis and treatment in a routine clinical setting. METHODS: Serum HER-2 was measured in 1348 patients with breast cancer: 837 during routine oncology clinic visits and 511 following new diagnosis. All patients with positive serum HER-2, 1/5 of negative patients from the oncology clinic, and all the newly diagnosed were followed; a total of 862 patients. Serum HER-2 was measured using the Bayer ADVIA Centaur assay. Tissue HER-2 was determined using immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). IHC +3 or IHC +2 and FISH>2.0 were positive. Patients were considered to have positive serum HER-2 when at least two values were >15 ng/mL. Recurrence, progression and regression were diagnosed according to usual clinical practice. Serum HER-2 concentrations did not contribute to diagnostic decision-making or selection of treatment. RESULTS: From January 2004 to January 2009, 149 patients were found to have positive serum HER-2. Of these, 35 were tissue HER-2 positive at surgery, 69 tissue-negative and 45 were not determined. Fifty-five of 149 that were serum HER-2 positive (37%, 95% CI: 29-45) had metastases. Among the 35 tissue-positive patients, 25 had recurrence in the form of metastases and there was good correlation between recurrence/progression and increase in serum HER-2 (p<0.0003). There was also a high correlation between effect of treatment and decline in serum HER-2 (p<0.0003). Of the 69 tissue-negative patients, 29 had recurrence in the form of metastases, and there was good correlation with serum HER-2 levels (p<0.000004). In this routine application of serum HER-2, the PPV for metastases recurrence detection in both tissue-positive and tissue-negative was 54 of 104 (52%, 95% CI: 42%-62%), in tissue-positive 25 of 35 (71%, 95% CI: 54%-85%), in tissue-negative 29 of 69 (42%, 95% CI: 30%-54%). The lead time of increases in serum HER-2 before recurrence could be determined in ten tissue-positive patients was 3-24 months (mean 11.3 months), when compared to standard clinical imaging methods. CONCLUSIONS: Serum HER-2 is a useful marker for the detection of recurrence of breast cancer and for monitoring the effect of treatment, especially in tissue HER-2 positive patients.

KW - Adult

KW - Aged

KW - Breast Neoplasms

KW - Disease Progression

KW - Female

KW - Humans

KW - Middle Aged

KW - Neoplasm Metastasis

KW - Neoplasm Recurrence, Local

KW - Receptor, erbB-2

U2 - 10.1515/CCLM.2009.241

DO - 10.1515/CCLM.2009.241

M3 - Journal article

VL - 47

SP - 1117

EP - 1123

JO - Clinical Chemistry and Laboratory Medicine

JF - Clinical Chemistry and Laboratory Medicine

SN - 1434-6621

IS - 9

ER -